Device recall
Z-0409-2013: RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of…
FDA device recall · Class II · KCI USA, Inc.
Key facts
| Recall number (Z-number) | Z-0409-2013 |
|---|---|
| Recall event | 62805 |
| Product | RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction |
| Product code | IOQ |
| Recalling firm | KCI USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2013 |
| FEI number | 1625774 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database